Disparities in breast cancer outcomes are unacceptable and will only improve with sustained, collective action. That’s why Susan G. Komen’s Center for Public Policy proudly supports the recently introduced NIH Clinical Trial Diversity Act (H.R.3503/S.1701), which builds upon the National Institutes of Health (NIH)’s current policies by working with clinical trial sponsors to develop clear and measurable goals related to diversity in all NIH-funded clinical trials.
Clinical trials are the primary way we learn about a treatment’s effectiveness in all patients. However, inequitable clinical trial access and participation leads to inequitable care and outcomes. We know that many clinical trials do not include participants who reflect the actual patient communities that will take a drug or use a product, which both reduces access to the most novel technologies but also can lead to inequitable health outcomes once on the market. Clinical trials often exclude people of color and those with comorbidities, which limits access to new treatments and increases the risk of severe side effects. To improve health equity, we need to make clinical trials more inclusive and ensure that all patients have access to the best possible care.
As the leading voice of the breast cancer community, we know this reality all too well. Research shows that widespread racial health disparities persist in breast cancer. For example, Black women are, on average, about 40% more likely to die of the disease as compared to white women.[1] Black women are also more likely than white women to be diagnosed with aggressive breast cancers, such as triple-negative breast cancer and inflammatory breast cancer, and are more likely to be diagnosed at a later stage, when treatments are limited and costly and the prognosis is poorer.[2] Breast cancer disparities also exist for other historically marginalized groups. It is the most common cancer diagnosed and the leading cause of cancer death for Hispanic/Latina women.[3] Similar to Black women, Hispanic and American Indian/Alaska Native women are more than 30% more likely to be diagnosed with advanced stage breast cancer compared with white women.[4]
Clinical trials afford breast cancer patients a unique opportunity to benefit from new and developing treatments and often result in the establishment of new best practices, novel and cutting-edge treatment methods, or new drugs and protocols. A diverse population of clinical trial participants increases the value and usefulness of trial results and helps to ensure that data on innovative drugs and devices developed are applicable to a more representative population of patients. Unfortunately, even though Black Americans make up 12% of the U.S. population, fewer than 5% of clinical trials participants are Black, and even fewer are Black women. Similarly, Hispanic Americans account for 18% of the total population but just 1% in clinical trials. Improving diversity in clinical trials will address some of the root causes for the health inequities in cancer, but to achieve this we must address accessibility. It is estimated today that only 27% of cancer patients have the option to enroll in a local clinical trial.[5]
The NIH Clinical Trial Diversity Act encourages enhanced inclusion of women and racially and ethnically diverse individuals in clinical trials by adding related conditions for funding from the NIH for a clinical trial investigating a drug or device. To receive NIH funds, the sponsor’s application must include information related to diversity in its trial, such as: goals for recruiting and retaining trial participants, plans for achieving the recruitment and retention goals, implementing less-burdensome clinical trial follow-up requirements, and education and training requirements related to diversity in clinical trials for researchers and other individuals who conduct or support the trial.
Improving diversity in clinical trials is an important step toward overcoming health disparities. It is not, however, the only improvement necessary. Other challenges impede participation in clinical trials by underrepresented communities, from community perception and distrust of both the government and medical providers to not even being offered the opportunity to participate in the first place. While most are never asked to participate in clinical trials, more than 50% of eligible patients asked to enroll will agree to do so.[6] Many more face additional systemic barriers including lack of diversity in the health care workforce, lack of geographic and financial access to services, systemic racism in health care, and prohibitive exclusionary criteria. These factors contribute to the failure of approximately 20% of clinical trials solely due to insufficient patient enrollment. Addressing these flaws in our health care system and by consequence making clinical trials more accessible — is critical to addressing health disparities.
[1] Howlader N. SEER cancer statistics review (CSR) 1975–2016. National Cancer Institute. Available from: https://seer.cancer.gov/csr/1975_2016/, based on November 2018 SEER data submission, posted to the SEER web site, April 2019.
[2] American Cancer Society. Breast Cancer Facts & Figures 2019-2020. (2019); Williams et al., 2016
[3] Power EJ. Breast Cancer Incidence and Risk Reduction in the Hispanic Population. Cureus. 2018;10(2):e2235. Published 2018 Feb 26. Doi:10.7759/cureus.2235
[4] AACR (2020).
[5] Barriers to Patient Enrollment in Therapeutic Clinical Trials for Cancer. American Cancer Society Cancer Action Network. Available at: https://www.fightcancer.org/policy-resources/barriers-patient-enrollment-therapeutic-clinical-trials-cancer.
[6] Barriers to Patient Enrollment in Therapeutic Clinical Trials for Cancer. American Cancer Society Cancer Action Network. Available at: https://www.fightcancer.org/policy-resources/barriers-patient-enrollment-therapeutic-clinical-trials-cancer.
